Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer

Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer

The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.

Inclusion Criteria:

• Locally advanced breast cancer diagnosed by guided core biopsy
• T > 2 cm (any N), or any T and node positive (needle biopsy is required)
• Non-metastatic disease assessed by computed tomography and bone scintigraphy
• Histological grade 2 and Ki67 > 15% or
• Histological grade 3 or
• Any triple negative (TN) or
• Inflammatory breast cancer (IBC)
• Normal left ventricular ejection fraction (LVEF)
• HER2-negative disease

Exclusion Criteria:

• Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
• Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
• LVEF value below institutional limits of normal
• Predominant lobular carcinoma histology
• Grade 1 tumors
• Detected or suspicious distant metastasis
• Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
• Male sex
• HER2-positive breast cancer